Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05134558
Status:
UNKNOWN
Last Update Posted:
2021-11-26
First Post:
2021-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-14', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-11-14', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of radiation pneumonia', 'timeFrame': 'Within 1 year of radiation therapy', 'description': 'Incidence of radiation pneumonia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'Radiation Therapy', 'Xenon-enhanced ventilation CT'], 'conditions': ['Lung Cancer', 'Radiation Therapy Complication']}, 'descriptionModule': {'briefSummary': "The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis.", 'detailedDescription': "There has been an increase in the application of radiation therapy in the treatment of lung tumors; however, the associated side effect, called radiation pneumonitis, can significantly reduce lung function and the quality of life of patients, eventually leading to fatal consequences. The investigators aim to use xenon-enhanced ventilation computed tomography (CT) to design personalized functional lung avoidance radiotherapy for lung cancer patients who are scheduled to receive lung radiation therapy. The investigators' goal is to optimally protect the lung function of the patients and reduce the incidence of radiation pneumonitis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20-80 years, with lung cancer receiving thoracic radiotherapy in NTUH, from February 2020 to December 2024.\n\nExclusion Criteria:\n\n* The age is less than 20 years old or older than 80 years old.\n* Unstable clinical condition, unable to maintain apnea for 15 second, and history of prior adverse reaction to xenon.\n* Renal insufficiency patients.\n* Claustrophobia\n* Those who are pregnant.'}, 'identificationModule': {'nctId': 'NCT05134558', 'briefTitle': 'Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Xenon-enhanced Ventilation CT-guided Radiotherapy for Lung Cancer Treatment: Functional Protection of the Lung and Prevention of Radiation Pneumonitis', 'orgStudyIdInfo': {'id': '201912128RIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xenon-enhanced Ventilation CT-guided Radiotherapy', 'description': 'Patients will be receiving Xenon-enhanced Ventilation CT-guided Radiotherapy for functional lung avoidance. The doses for the tumors, lungs, and organs at risk will be examined and evaluated.', 'interventionNames': ['Radiation: Xenon-enhanced Ventilation CT-guided Radiotherapy']}], 'interventions': [{'name': 'Xenon-enhanced Ventilation CT-guided Radiotherapy', 'type': 'RADIATION', 'description': 'Xenon-enhanced Ventilation CT-guided Radiotherapy for functional protection of the lung', 'armGroupLabels': ['Xenon-enhanced Ventilation CT-guided Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Sen Huang, MD PhD', 'role': 'CONTACT', 'email': 'yusen0814@gmail.com', 'phone': '+886-23123456'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yu-Sen Huang, Md PhD', 'role': 'CONTACT', 'email': 'yusen0814@gmail.com', 'phone': '+886-23123456'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}